Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Stroke Fast Pack(TM)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Stroke Fast Pack(TM)see related information
Date Initiated by FirmNovember 03, 2017
Date PostedDecember 05, 2017
Recall Status1 Terminated 3 on November 04, 2019
Recall NumberZ-0276-2018
Recall Event ID 78607
510(K)NumberK113260 K113778 K132641 K143077 K151667 
Product Classification Catheter, thrombus retriever - Product Code NRY
ProductStroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 4 mm, 20 mm, ; Trevo(TM) Pro 18, TREVO PRO 18 MICROCATHETER, 0.021 in ID, 150 cm; AXS Catalyst(TM) 6, Distal Access Catheter, 0.060 in, 132 cm; UPN M0033PK42022002 Stroke intervention kit
Code Information Lot Number QPC30200039, Exp. Date 28-Aug-18; QPC30200114, Exp. Date 28-Mar18
Recalling Firm/
Manufacturer		 Stryker Neurovascular
47900 Bayside Pkwy
Fremont CA 94538-6515
For Additional Information ContactAngela Beckman
510-413-2900
Manufacturer Reason
for Recall		Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve label contents did not match the physical contents within the pack.
FDA Determined
Cause 2		Labeling Change Control
ActionThe firm, Stryker Neurovascular, sent an "Urgent Medical Device Voluntary Recall Immediate Action Required" letter initiating their recall on 11/01/2017. The letter described the product, problem and actions to be taken. The consignees were instructed to immediately check internal inventory; remove and discard the procedure pack carton sleeve; circulate notice; maintain awareness of notice internally until all required actions have been completed with your facility; inform Stryker of any subject devices distributed to other organization, and complete and return customer response form to your nominated Stryker Representative or to NVFieldActions@stryker.com. If you have any questions, call 510-413-2593; email: geraldine.ahern@stryker.com or 510-413-2900.
Quantity in Commerce2 units
DistributionInternational Distribution to: Germany, Slovakia and Israel.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = NRY
510(K)s with Product Code = NRY
510(K)s with Product Code = NRY
-
-